Medicus Pharma Publishes Abridged Final Phase 2 SkinJect® Clinical Study Report (CSR) Results Identifying 200 µg D-MNA Patch as the Lead Development Dose

PHILADELPHIA, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, today announced that an abridged Clinical Study Report (CSR) for SKNJCT-003 (NCT06608238) has been posted on ClinicalTrials.gov, providing transparent public access to the efficacy, safety, drug-delivery and clinical findings from the completed Phase 2 study. 

Publication of the abridged CSR represents an important scientific milestone for SkinJect® and provides a transparent public record of the completed Phase 2 findings. The Company believes the dataset provides the clinical foundation for its focused development strategy, prioritizing the FDA-authorized SKNJCT-005 program in Gorlin syndrome patients with multiple basal cell carcinoma lesions, while pursuing strategic partnership opportunities to advance SkinJect® in nodular basal cell carcinoma (BCC).

The randomized, double-blind, multicenter Phase 2 study enrolled 90 patients across ten U.S. investigative sites and evaluated two dose levels of SkinJect® compared with a device-only microneedle comparator. All 90 enrolled patients completed the study without treatment discontinuations or study withdrawals, providing a complete clinical dataset for efficacy and safety evaluation.

The completed SKNJCT-003 CSR represents the definitive analysis of the Phase 2 program and incorporates the full clinical, pathological, and translational dataset generated during SKNJCT-003. Final efficacy analyses were conducted in the modified intent-to-treat population representing patients with centrally confirmed nodular basal cell carcinoma, providing what the Company believes to be the most clinically relevant assessment of SkinJect®’s therapeutic performance in its intended target population.

Dr. Faisal Mehmud, Chief Medical Officer of Medicus, commented:

“Publication of the SKNJCT-003 abridged Clinical Study Report is an important milestone in the development of SkinJect®. We believe that the completed Phase 2 study has provided the clinical information needed to define the next stage of development, including selection of the 200-mcg dose, continued improvement in clinical and histological clearance with longer follow-up, a favorable safety profile and important learnings around study design and assessment timing. These findings directly informed our FDA-authorized SKNJCT-005 program in Gorlin syndrome and provide a defined development package that we believe can support discussions with potential strategic partners interested in advancing SkinJect® in nodular basal cell carcinoma.”

Phase 2 Results Support a Focused, Capital-Efficient Development Strategy

Beyond reporting the efficacy and safety findings from SKNJCT-003, the completed Phase 2 program has defined key scientific elements relevant to future SkinJect® development, including dose selection, efficacy endpoints, assessment timing, comparator selection and statistical design. Medicus is applying these learnings to its FDA-authorized new drug application (NDA)-enabling development program in Gorlin syndrome patients and believes the same body of evidence can support a potential strategic partner in advancing a registrational program in nodular basal cell carcinoma.

The scientific conclusions documented in the CSR include:

• Selection of the 200 µg SkinJect® patch as the proposed pivotal dose.
• Adoption of a composite complete response endpoint incorporating both clinical and histological clearance.
• Selection of a later primary efficacy assessment, reflecting continued improvement in treatment response observed with longer follow-up.
• Replacement of the biologically active device-only comparator with a non-penetrating sham comparator designed to better isolate the pharmacologic contribution of SkinJect®.
• A randomized, double-blinded, sham-controlled registrational study intended to generate a robust, decision-grade clinical dataset.
• A statistical design providing approximately 90% power to detect a clinically meaningful treatment difference while supporting discussions with FDA regarding a potential single pivotal study approach.
  

Collectively, these findings provide a scientific bridge from the completed SKNJCT-003 study to the Company’s current SkinJect® strategy, where the Company believes the platform has the potential for greater clinical differentiation, a more focused regulatory pathway and attractive rare-disease commercial economics in treating Gorlin syndrome patients with multiple BCC lesions, while preserving the broader opportunity in nodular BCC through potential strategic partnering.

Medicus intends to continue clinical development through SKNJCT-005, in Gorlin syndrome, a rare autosomal dominant disease in which patients can develop numerous BCC lesions throughout their lifetime, frequently requiring repeated surgical or other lesion directed procedures. Approximately 11,000 patients with Gorlin syndrome in the United States are estimated to have active BCC, representing approximately 50,000 Gorlin-associated BCC procedures annually. The U.S. Food and Drug Administration has issued a “Study May Proceed” letter authorizing initiation of the Company’s NDA-enabling registrational Phase 2b clinical study, SKNJCT-005, evaluating SkinJect® 200 µg skin patch in patients with Gorlin syndrome presenting with multiple BCCs. The study is designed to enroll up to approximately 50 patients.

The Company believes concentrating SkinJect® development on Gorlin syndrome could provide several potential strategic advantages beyond the more broadly competitive sporadic BCC market. Medicus has submitted applications to the FDA for Orphan Drug Designation (“ODD”) and Rare Pediatric Disease (“RPD”) designation. If granted and applicable statutory requirements are ultimately satisfied, these designations could provide important regulatory and economic benefits, including potential orphan-drug incentives and potential eligibility for a Rare Pediatric Disease Priority Review Voucher (“RPD PRV”).

The Gorlin-focused strategy may also potentially support a differentiated reimbursement profile. A Company-commissioned 2026 independent commercial assessment incorporating interviews with physicians and payers modeled rare-disease-anchored net pricing of approximately $25,800 per treatment, an implied U.S. total addressable market of approximately $1.1 billion, and potential peak U.S. revenue of approximately $383 million. These estimates are non-risk-adjusted and dependent upon successful clinical development, regulatory approval, reimbursement and commercial adoption.

Scientific Dissemination

Publication of the abridged Clinical Study Report and public availability of the SKNJCT-003 results represent the first step in the Company’s broader scientific dissemination strategy. Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming major international scientific congress and for publication in a leading peer-reviewed medical journal, further supporting independent review of the study findings and continued engagement with the global dermatology and oncology communities; however, there is no guarantee that such dataset will be accepted for presentation or for publication.

For further information contact:

Carolyn Bonner, President and Chief Financial Officer
(610) 636-0184
cbonner@medicuspharma.com

Anna Baran-Djokovic, SVP Investor Relations 
(305) 615-9162
adjokovic@medicuspharma.com

About Medicus Pharma Ltd.

Medicus Pharma Ltd. (Nasdaq: MDCX) is a precision-guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets. The Company is actively engaged in multiple countries across three continents.

The Company’s current therapeutic assets are:

CD228V ADC, an investigational antibody-drug conjugate molecule utilizing Pfizer’s established vedotin linker-payload platform, directed against melanotransferrin (CD228), a cell-surface protein expressed across multiple solid tumor types, such as melanoma, squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and esophageal cancer.

SkinJect®, an investigational novel localized immuno-oncology precision product focused on non-melanoma skin diseases, especially basal cell carcinoma (BCC) lesions in Gorlin Syndrome patients, a rare autosomal dominant disease also called nevoid BCC syndrome.

Teverelix®, an investigational next-generation GnRH antagonist, is being developed as a first-in-market product for cardiovascular high-risk advanced prostate cancer patients, patients with acute urinary retention relapse (AURr) episodes due to enlarged prostate and symptomatic endometriosis.

Medicus’ strategy is to advance select programs through Phase 2 proof-of-concept and key clinical and regulatory inflection points that substantially reduce development risk and increase their attractiveness to potential pharmaceutical partners. By generating decision-grade clinical, regulatory and operational datasets, the Company seeks to create opportunities for strategic collaborations, regional licensing transactions and broader commercialization partnerships with established pharmaceutical companies. As data matures across its programs, Medicus intends to continue building differentiated development packages designed to maximize asset value while maintaining capital efficiency and development focus.

Cautionary Notice on Forward-Looking Statements

Certain information in this news release constitutes “forward-looking statements” or “forward-looking information” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws (collectively, “forward-looking statements”). “Forward-looking statements” are defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the development of SkinJect® and the potential benefits thereof for those suffering with Gorlin Syndrome, the posting of the abridged SKNJCT-003 CSR and the Company’s interpretation and characterization of the data contained therein, the selection of the 200-mcg dose as the proposed pivotal dose, the Company’s strategy to prioritize continued clinical development of SkinJect® in Gorlin syndrome, the initiation, conduct and results of SKNJCT-005, the Company’s efforts to identify and enter into strategic collaborations, licensing arrangements or other partnerships for development of SkinJect® in nodular basal cell carcinoma, the design, timing, conduct and results of any future partner-led nodular basal cell carcinoma study and whether the resulting data will be sufficient to support a future New Drug Application for SkinJect®, whether the FDA will grant Orphan Drug Designation or Rare Pediatric Disease designation for SkinJect® in Gorlin Syndrome and the benefits of any such designation, if granted, the potential pricing of, and reimbursement for, SkinJect®, if approved, and the estimates of net price per treatment, total addressable market and potential peak U.S. revenue described in this news release, Antev’s future, the development of Teverelix® and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix® for AURr, cardiovascular high-risk advanced prostate cancer, women’s health indications like endometriosis, the Company’s co-development with Pfizer with respect to CD228V and the anticipated benefits thereof, the Company’s plans and expectations relating to the development, manufacture and commercialization of CD228V across human therapeutic indications, including the Company’s intention to focus initial development on melanoma with potential subsequent development in squamous non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and esophageal cancer, the timing, design, conduct and results of any future clinical study of CD228V, and the potential market opportunities related to CD228V, SkinJect® and Teverelix® and the Company’s other therapeutic assets. Forward-looking statements are often, but not always, identified by the use of such terms as "may", “on track”, “aim”, "might", "will", "will likely result", “could,” “designed,” "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", “potential” or the negative and/or inverse of such terms or other similar expressions. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's annual report on form 10-K for the year ended December 31, 2025, and in the Company's other public filings on EDGAR and SEDAR+, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.